Vaginal and rectal applicators have been used to dispense medications to treat vaginal diseases and disorders and diseases of the lower abdomen including the colon and rectum. They are sold both pre-filled and empty. For example, SCHERING-PLOUGH® Health Care Products, Memphis, Tenn., provides applicators for GYNE-LOTRIMIN®. Additionally, Ortho McNeil and Columbia Laboratories supply pre-filled applicators for dispensing a contraceptive gel and vaginal moisturizer, respectively. Generally, the vaginal applicator consists of an elongated small diameter cylindrical barrel and a plunger rod.
Vaginal and rectal applicators have traditionally been designed to deliver large volumes (e.g. greater than 1 mL) of pharmaceutical preparations. Vaginal applicators are typically used to delivery large volumes of drug for the treatment of diseases and disorders within the vagina, while rectal applicators have been used to treat diseases of the lower abdomen and bowel using large volumes of drug in the form of enemas, foams and suppositories. When such large volumes of drugs are delivered, they coat the entire vaginal epithelia, in the case of vaginal delivery, or anal canal, in the case of rectal delivery. The large volume of medication contained within the applicator poses aesthetic concerns and hygiene issues. Further, the amount of drug dispensed is often imprecise, which may result in over- or under-dosing.
Therefore it is an object of the invention to provide vaginal or rectal applicators that are able to precisely deliver small amounts of pharmaceutical compositions.
It is a further object of the invention to provide vaginal or rectal applicators for transvaginal or transrectal delivery of pharmaceutical compositions for regional administration.